Sunday, August 3, 2008

What if there was a magic pill that alcoholics and addicts could take to stop their cravings?

Steve Ayers, an Aspen doctor, and Annie Brown, an Aspen nurse with a clinical specialty, don't claim to have a magic pill.

But they do claim to have something almost as useful: a drug cocktail that can relieve cravings, reduce sleeplessness, restore normal brain function, and help patients feel better so that they can fully engage in recovery.

Brown and Ayers, who also is chief of staff at Aspen Valley Hospital, an emergency room physician, and the Pitkin County coroner, are convinced the program does what it claims, and they are backed by several studies. But nationwide, some critics have argued that the treatment, needs more study and/or approval from the Food and Drug Administration (FDA).

A combination of three drugs (flumazenil, hydroxyzine, and gabapentin), nutritional therapy, and psycho-social counseling, the Prometa treatment program was developed by a Spanish doctor in the 1990s. Since Terren Peizer bought the protocols and began marketing it, approximately 3,000 patients have been treated in the United States, according to Brown.

Treatment begins with a three-day infusion of flumazenil, given intravenously for three- to five-minute intervals while the patient's cardiac state is monitored.The flumazenil infusion is followed by dosages of hyroxyzine, gabapenin and nutritional supplements over a 39-day period.

The drugs help change the anatomy and chemistry of the brain to return addicts to a pre-addiction state in which they do not have a physiological dependence on the drug, said Ayers. In short, it allegedly reduces cravings.

“You can remodel [brain tissue] quickly with the right influence. That's how you learn a new skill, like throwing a Frisbee. Your brain tissue is actually forming new cells,” explained Ayers.

The partners, who are the only people licensed to administer the protocol in Colorado or Wyoming, say the program has been even more successful than they'd hoped. While not all their clients have achieved sobriety without relapse, all patients claim their cravings have been reduced, they say.

“I've been working 25 years with addiction — this is the most robust intervention, the best tool I've had,” Brown said.

Their clients, in e-mails forwarded by Brown, are equally glowing.

“What Prometa did for me I cannot put into words,” wrote one recovering alcoholic.Another patient, who earned a college scholarship after kicking his cocaine addiction, cautioned that Prometa is not a magic pill, but is “the wind in the sails of those that are ready.”

A third testified to its effect on his psyche: “Before Prometa I had cravings all the time. All I could think about was drinking. After Prometa the cravings have decreased … if I am at lunch and I see someone drinking, I think about ordering a drink and then I don't.

Critics

Not everyone in the medical community has given wholehearted support for the treatment. Prometa has had several public-relations challenges, perhaps chief among them the fact that Terren Peizer, who owns and markets the treatment program through his company Hythiam, is former junk bond salesman.

Given the cost of the treatment, Peizer — who visited Aspen last summer as an Aspen Institute panelist for a bioethical dilemmas seminar — stands to become a very wealthy man. Aspen treatments, for example, cost $12,000 to $18,000, a portion of which is returned to Peizer as a “licensing fee.”

Also, Peizer has not sought approval from the FDA for the treatment protocol. Technically, he does not have to, as the drugs have individually received FDA approval for other uses.

Opponents have also argued the protocol hasn’t been thoroughly and independently studied. An October 2007, Hythiam-funded study, led by Dr. Harold C. Urschel and published in the Mayo Clinic Proceedings medical journal, was criticized for not having a control group or placebo. The television show 60 Minutes later reported that Dr. Urschel's clinic sold the Prometa treatment during the trial, suggesting that doing so was a conflict-of-interest.

Several other “double-blind” studies have since been held with control groups and placebos, and have found that Prometa reduces cravings. But none have yet been peer-reviewed in a medical journal, note critics.

But Ayers and Brown say that not all the criticisms are valid.

Ayers countered that many medical protocols have never been studied. For example, he said, every alcoholic who is admitted to an emergency room in America gets a shot of thiamine, the dosage of which has never been studied.

“There's a million things in medicine that are considered standard of care and scientifically founded that are not double-blind studied,” he said.

Having said that, he did acknowledge that Prometa should be “if people are going to pay that much for it.”

On the topic of FDA approval, he argued that the FDA doesn't approve protocols, only drugs. Many drugs are now prescribed for a use other than their approved use, he said.

Brown countered concerns about cost by noting that Hythiam has said its first priority this year is to convince managed care programs to pay for Prometa. Acknowledging that some never will (many insurance companies don't cover drug and alcohol treatment), she also pointed out the high cost of addiction, a number that can easily top the cost of Prometa, given time.

Brown also noted that $1,500 of the fee goes toward therapy in the person’s hometown.

Future

Prometa is revolutionary, say Brown and Ayers, because it claims to reduce cravings. But for years, treatment centers have used drugs to help manage addiction.Perhaps the most famous is Antabuse, which makes the alcoholic very ill if he or she drinks. Vivitrol, a short-term immunization that blocks alcohol's ability to work on the brain, has also been used with some success.

But Ayers argues that Prometa, and the drug protocols that will likely follow it in the next few years, are the future of addition medicine. Within two years, he predicted, all addictions will likely be treated medically — and the medical community will laugh about the fact that it ever considered addiction to be simply a behavioral problem.“The addiction medical community is all over this concept of treating [addiction] medically and finding different ways to treat it,” he said.

He even predicted that doctors might be able to provide immunizations to protect children with a family history of addiction, some day. Immunized people would be able to snort cocaine, but it would have no effect on their brain.

“All these things are going to create ethical dilemmas in medicine,” he said. “How do you immunize someone? How do you take away their ability to experience cocaine?”____________kredding@aspentimes.comThe Aspen Times